FIDES-03: This Phase I/II trial is trying to understand whether it is better to use a certain type of targeted therapy (derazantinib) alone or in combination with other types of therapy in patients with stomach or gastro-oesophageal cancerA Phase 1b/2 Study of Derazantinib as Monotherapy and Combination Therapy With Paclitaxel, Ramucirumab or Atezolizumab in Patients With HER2-negative Gastric Adenocarcinoma Expressing FGFR2 Genetic Aberrations

Exclusion

• Prior anticancer or investigational drug treatment within an interval shorter than the following, as applicable:

  1. One chemotherapy or biological (e.g., antibody) cycle interval
  2. Five half-lives of any small molecule investigational or licensed medicinal product
  3. Two weeks, for any investigational medicinal product with an unknown half-life
  4. Four weeks of curative radiotherapy
  5. Seven days of palliative radiotherapy
• Prior treatment with FGFR Inhibitors (all substudies), and prior treatment with taxanes within 6 months prior to randomization and/or anti-VEGF(R) therapeutic antibody or pathway-targeting agents (Substudies 2 and 3), and prior treatment with anti-programmed cell death receptor-1 (PD-1) or anti-programmed death ligand-1 (PD-L1) therapeutic antibody or pathway-targeting agents (Substudy 3)
• Concurrent evidence of clinically significant corneal or retinal disorder
• History of clinically significant cardiac disorders and/or a QT interval corrected by Fridericia's formula (QTcF) > 450 ms for males or > 460 ms for females
• Known CNS metastases
• Concurrent uncontrolled or active infection with human immunodeficiency virus (HIV; known HIV 1/2 antibodies positive); active or chronic hepatitis B without current antiviral therapy and an HBV DNA ≥ 100 IU/mL virus (HBV); active hepatitis C virus (HCV) co-infection; active tuberculosis (for Substudies 2 and 3)
• Child-Pugh B or C liver cirrhosis, or a history of hepatic encephalopathy, hepatorenal syndrome, or clinically-meaningful ascites related to cirrhosis (for Substudies 2 and 3)
• Administration of a live, attenuated vaccine within 30 days prior to randomization (for Substudy 3)
• Treatment with systemic corticosteroids (except for steroidal replacement therapy) or other systemic immunosuppressive medications within 2 weeks prior to first dose of study drug or anticipated requirement for systemic immunosuppressive medications during the study (for Substudy 3)